US9925355B2 - Intermittent catheter assembly and kit - Google Patents

Abstract

An intermittent catheter assembly and kit comprising an elongated introducer element formed of a flexible material adapted for insertion into a urethra during a catheterization procedure. The introducer element has at least one slit extending longitudinally along a substantial portion of its length. The catheter assembly also includes an applicator having an opening, and a sheath having a first end that is secured to the applicator about the opening. The sheath also has a second end defining a discharge opening which is inverted relative to the first end of the sheath to define inner and outer sleeve portions. The inner sleeve portion defines a flow path for urine through the discharge opening. The applicator receives the introducer element through the opening and extends the outer sleeve portion over an outer surface of the elongated introducer element to separate it from the urethra.

Description

RELATED APPLICATION

This application is a U.S. National Stage of PCT International Patent Application No. PCT/US2013/031230, filed Mar. 14, 2013, which claims the benefit of and priority to U.S. Provisional Patent Application Ser. No. 61/725,311, filed Nov. 12, 2012, both of which are incorporated by reference herein.

FIELD OF THE DISCLOSURE

The present disclosure is generally directed to an intermittent catheter assembly adapted for a user to insert the catheter through the urethra to drain urine from the bladder and, more particularly, to an intermittent catheter assembly and kit with a reusable insertion component for use with a single-use, component which may be disposable, for example, by flushing it down a toilet.

BACKGROUND OF THE DISCLOSURE

Intermittent catheter assemblies are a good option for many users who suffer from various abnormalities of the urinary system. A common situation is where single-use, packaged, ready-to-use sterile catheters are utilized. An important criterion for single-use, ready-to-use products is that they be entirely user-friendly under a wide variety of different conditions.

Among those requiring intermittent catheterization on a regular and recurring basis are users who lead relatively mobile lives. There has been a continuing need for improved intermittent catheter assemblies for such users so they are able to carry with them the requisite number of catheters in a convenient and discrete manner so as to be able perform self-intermittent catheterization several times per day. However, intermittent catheter assemblies that have been available for self-catheterizing have often been provided in long, narrow bulky packages.

While it is possible in some instances to fold the packages so they can be carried in a pocket, even a single packaged intermittent catheter assembly of this type tends to be quite bulky. It is also the case that such intermittent catheter assemblies do not lend themselves to discrete disposal, and no portion of such intermittent catheter assemblies is reusable. As a result, the freedom self-catheterizing could provide has not been fully achieved due to the absence of suitable products that are disposable in a discrete manner in packages of reduced size.

In addition, existing intermittent catheter assemblies have relatively thick-walled catheter tubes formed of polymeric materials, and they typically have been single-use items that are discarded after they are used one time. As will be appreciated, this presents a significant problem due to the large amount of waste material which is created, especially considering the number of users who perform self-intermittent catheterization multiple times per day.

To provide an intermittent catheter assembly suitable for users having relatively normal mobility, it is important to consider various aspects of self-catheterization. These include providing catheter assemblies that will facilitate i) carrying a supply which is sufficient to permit a user to self-catheterize several times a day, ii) inserting catheter assemblies in a manner which does not compromise sterility, iii) draining urine from the human bladder in an efficient and effective manner, and iv) discretely discarding at least the portion of each of the assemblies through which urine is drained. If these aspects of self-catheterization could be addressed, a person having relatively normal mobility would be better able to live an essentially unrestricted lifestyle.

SUMMARY OF THE DISCLOSURE

There are several aspects of the present subject matter which may be embodied separately or together in the devices and systems described and claimed below. These aspects may be employed alone or in combination with other aspects of the subject matter described herein, and the description of these aspects together is not intended to preclude the use of these aspects separately or the claiming of such aspects separately or in different combinations as set forth in the claims appended hereto.

In one aspect, an intermittent catheter assembly includes an elongated introducer element that has a proximal insertion end and a distal end remote from the proximal insertion end. The elongated introducer element is formed of a flexible material adapted for insertion into a urethra during a catheterization procedure and has at least one slit extending longitudinally along at least a portion thereof. The assembly also includes a sheath having a first end and a second end being inverted relative to the first end of the sheath to define inner and outer sleeve portions and a space therebetween. The inner sleeve portion defines a flow path for urine. The elongated introducer element is disposed in the space defined between the inner and outer sleeve portions. The inner sleeve portion is extendable through the at least one slit of the elongated introducer element so as to be disposed within the elongated introducer element and cover an inner surface of the elongated introducer element. The inner sleeve portion separates the inner surface of the elongated introducer element from the urine flow path. Additionally, the outer sleeve portion extends over an outer surface of the elongated introducer element to separate the outer surface of the elongated introducer element from the urethra.

In another aspect, an intermittent catheter assembly includes an elongated introducer element that has a proximal insertion end and a distal end remote from the proximal insertion end. The elongated introducer element is formed of a flexible material adapted for insertion into a urethra during a catheterization procedure. Additionally, the elongated introducer element has at least one slit extending longitudinally along at least a portion thereof. The assembly also includes an applicator that has an opening for receiving the elongated introducer element and a sheath that has a first end secured to the applicator about the opening. The sheath also has a second end that defines a discharge opening. The second end of the sheath is inverted relative to the first end of the sheath and extends into the opening of the applicator to define inner and outer sleeve portions. Additionally, the inner sleeve portion defines a flow path for urine through the discharge opening. The assembly further includes a holding element that is associated with the second end of the sheath for extending the inner sleeve portion through the at least one slit of the elongated introducer element so as to dispose the inner sleeve portion within the elongated introducer element. The inner sleeve portion covers an inner surface of the elongated introducer element to separate the inner surface of the elongated introducer element from the urine flow path. As the elongated introducer element is inserted through the opening of the applicator, the outer sleeve portion extends over an outer surface of the elongated introducer element to separate the outer surface from the urethra.

In another aspect, an intermittent catheter assembly includes an elongated introducer element that has a proximal insertion end and a distal end remote from the proximal insertion end. The elongated introducer element is formed of a flexible material adapted for insertion into a urethra during a catheterization procedure. The elongated introducer element has at least one slit extending longitudinally along at least a portion thereof. The assembly also includes an applicator that has at least one opening for receiving the elongated introducer element and a drainage lumen for the drainage of urine. The assembly also includes a sheath having a first end and a second end being inverted relative to the first end of the sheath to define inner and outer sleeve portions and a space therebetween. The inner sleeve portion defines a urine flow path. The first end of the sheath is secured to the applicator about the at least one opening of the applicator. The opening of the applicator is in communication with the space defined between the inner and outer sleeve portions. The second end of the sheath is secured to the applicator about the drainage lumen wherein the urine flow path defined by the inner sleeve portion is in fluid communication with the drainage lumen of the applicator. The elongated introducer element is insertable through the opening of the applicator and into the space defined between the inner and outer sleeve portions. The outer sleeve portion extends over an outer surface of the elongated introducer element and the inner sleeve portion extends through the slit and covers an inner surface of the elongated introducer element to separate the inner surface of the elongated introducer element from the urine flow path.

In yet another aspect, an intermittent catheter assembly comprising an elongated introducer element formed of a flexible material adapted for insertion into a urethra during a catheterization procedure. The introducer element has at least one slit extending longitudinally along at least a substantial portion of its length. The catheter assembly also includes an applicator having an opening, and a thin sheath having a first end is secured to the applicator about the opening. The thin sheath also has a second end defining a discharge opening which is inverted relative to the first end of the sheath and extends into the opening in the applicator to define inner and outer sleeve portions. The inner sleeve portion defines a flow path for urine through the discharge opening. The catheter assembly also includes a holding element associated with the second end of the sheath for extending the inner sleeve portion through the slit(s) to be disposed within the introducer element. This serves to separate an inner surface of the introducer element from the urine flow path so the introducer element is never exposed to urine during a catheterization procedure. The applicator receives the introducer element through the opening and extends the outer sleeve portion over an outer surface of the elongated introducer element to separate it from the urethra. Accordingly, the portion of the introducer element which is located within the urethra during a catheterization procedure is entirely covered by the inner and outer sleeve portions of the sheath and is therefore suitable for reuse.

In an exemplary embodiment, the introducer element comprises a tube having a single slit which extends along the entire length thereof from a proximal insertion end to a distal end remote therefrom. The proximal insertion end of the introducer element is advantageously beveled to be at other than a right angle to an axis of the introducer element to aid insertion into a urethra during a catheterization procedure. Preferably, to aid insertion into the urethra, it has been found desirable for the proximal insertion end of the introducer element to be beveled so as to be at an angle of between about 15° and about 30° to an axis of the introducer element.

With regard to the slit extending longitudinally along at least a substantial portion of the length of the elongated introducer element, it may advantageously have a width of between about 1.0 mm and 1.5 mm. As for the applicator, it may suitably comprise a collar generally surrounding the first end of the thin sheath and also defining a stop during insertion of the elongated introducer element into a urethra.

As for the holding element, it may advantageously comprise a cord having a first end which is attached to the second end of the thin sheath, and the cord may also have a second end with a finger grip tab attached thereto. In an alternative embodiment, the second end of the thin sheath is secured to generally diametrically opposed portions of the applicator to define the holding element which is associated with the first end of the sheath. In this embodiment, the introducer element has a pair of opposed slits extending longitudinally along a substantial portion of the introducer element from a proximal insertion end toward a distal end thereof.

Still other features and advantages of the present disclosure will become apparent from the following specification taken in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an intermittent catheter assembly including an introducer element, an applicator, and a thin sheath in accordance with the present disclosure;

FIG. 2 is a front elevational view of the catheter assembly ofFIG. 1 with an inner sleeve portion of the sheath extended through a slit and disposed within the introducer element;

FIG. 3 is a front elevational view of the catheter assembly ofFIG. 1 with an outer sleeve portion of the sheath extended over an outer surface of the introducer element in a use position;

FIG. 3A is an enlarged cross-sectional taken from the area within circle3A ofFIG. 2;

FIG. 4 is a perspective view of the catheter assembly ofFIG. 3 in which the catheter assembly is ready for insertion into the urethra to perform a catheterization procedure;

FIG. 5 is a perspective view of the catheter assembly ofFIG. 4 in which the inner and outer sleeve portions are being removed from the introducer element for disposal;

FIG. 6 is a perspective view of an intermittent catheter assembly kit in a package containing an introducer element and a plurality of individually packaged sheaths;

FIG. 7 is a top plan view of a small condom style package containing a single sheath secured to an applicator and having a holding element associated with the sheath;

FIG. 7A is a top plan view similar toFIG. 7 illustrating the small condom style package containing a single sheath secured to an applicator after the package has been opened;

FIG. 8 is a perspective view of a single sheath secured to an applicator and having a holding element associated with the sheath after removal from the package ofFIG. 7A;

FIG. 9 is a front elevational view of an alternative embodiment of an intermittent catheter assembly with an inner sleeve portion of a sheath being extended through a pair of slits in an introducer element and an outer sleeve portion being disposed over the introducer element;

FIG. 10 is a front elevational view of the alternative embodiment of the intermittent catheter assembly ofFIG. 9 with the inner and outer sleeve portions disposed in a use position;

FIG. 10A is an enlarged cross-sectional view taken from the area within circle10A inFIG. 10;

FIG. 11 is a perspective view of the introducer element ofFIG. 9 illustrating the pair of slits diametrically opposed within and along a substantial portion of a tube;

FIG. 12 is a schematic view of the inner and outer sleeves of the thin sheath ofFIG. 9 before extending them by inserting the introducer element into the open space between them;

FIG. 13 is a perspective view of an applicator, sheath and holding element for the intermittent catheter assembly ofFIG. 9 with a peel-off lid being removed therefrom;

FIG. 14 is a perspective view of the applicator, sheath and holding element after the peel-off lid has been removed therefrom ready for insertion of the introducer element;

FIG. 15 is a perspective view of a package containing an introducer element and a plurality of individually packages each containing an applicator, sheath and holding element;

FIG. 16 is an exploded perspective view of another catheter assembly of the present disclosure;

FIG. 17 is a partial perspective view of the applicator and sleeve ofFIG. 16;

FIG. 18 is another partial perspective view of the applicator and sleeve ofFIG. 16 shown for another direction;

FIGS. 19 and 20 are perspective views of the package shown inFIG. 16;

FIGS. 21 and 22 are perspective views of the package ofFIG. 16 shown with the applicator and sleeve therein;

FIG. 23 is perspective of the catheter assembly ofFIG. 16 shown prior to insertion of the introducer element into the package;

FIGS. 24 and 25 are partial perspective views showing the introducer element ofFIG. 16 being inserted into the applicator and sleeve;

FIG. 26 is a perspective view of the catheter assembly ofFIG. 16 shown with the introducer element inserted into the applicator and sleeve;

FIGS. 27 and 28 are perspective views of another embodiment of an applicator and sleeve shown within a package;

FIG. 29 is a perspective view of the applicator shown inFIG. 27;

FIGS. 30-33 are partial perspective views showing an introducer element being inserted into the applicator ofFIG. 27;

FIGS. 34 and 35 are perspective view showing an introducer element being inserted into the applicator with the package shown inFIG. 27;

FIG. 36 is perspective view of the introducer element fully inserted into the applicator and sleeve ofFIG. 27;

FIGS. 37 and 38 are perspective views of another embodiment of an introducer element of the present disclosure;

FIG. 39 is a plan view of exemplary proximal insertion ends of the introducer element ofFIGS. 37 and 38;

FIG. 40 is a perspective view of another embodiment of a sleeve of the present disclosure; and

FIGS. 41-43 are perspective views of showing an introducer element being inserted into the sleeve ofFIG. 40.

DETAILED DESCRIPTION OF THE DISCLOSURE

In the illustrations given, and first with reference toFIGS. 1-5, thereference numeral20 designates generally an intermittent catheter assembly comprising anelongated introducer element22 which may be formed of a flexible material and is adapted for insertion into a urethra during a catheterization procedure. Theintroducer element22 has at least one slit24 extending longitudinally along a portion of its length and preferably at least a substantial portion of its length. Thecatheter assembly20 also includes an applicator generally designated26 which has anopening28, and a thin sheath, sleeve orshroud30 having afirst end30ais secured to theapplicator26 about theopening28. Thethin sheath30 also has asecond end30bdefining adischarge opening32 which is inverted relative to thefirst end30aof thesheath30 and extends into theopening28 in theapplicator26 to define inner34aand outer34bsleeve portions. Theinner sleeve portion34adefines a flow path33 (as illustrated inFIG. 3A) for urine through thedischarge opening32. Thecatheter assembly20 also includes a holdingelement36 associated with thesecond end30bof thesheath30 for extending theinner sleeve portion34athrough the slit(s) such as24 to be disposed within theintroducer element22. This serves to separate aninner surface22aof theintroducer element22 from the urine flow path so theintroducer element22 is never exposed to urine during a catheterization procedure. Theapplicator26 receives theintroducer element22 through theopening28 and extends theouter sleeve portion34bover anouter surface22bof theelongated introducer element22 to separate it from the urethra. Referring toFIG. 3A,sleeve30 everts over the proximal insertion end38 ofintroducer element22 so that theouter sleeve portion34bextends overouter surface22bandinner sleeve portion34aextends overinner surface22aofintroducer element22. Accordingly, the portion of theintroducer element22 which is located within the urethra during a catheterization procedure is entirely covered by the inner34aand outer34bsleeve portions of thesheath30 and is therefore suitable for reuse, as shown inFIG. 3A.

In an exemplary embodiment, theintroducer element22 comprises a tube having asingle slit24 which extends along the entire length thereof from aproximal insertion end38ato adistal end38bremote therefrom. Theproximal insertion end38aof theintroducer element22 may be beveled to be at other than a right angle to thelongitudinal axis40 of theintroducer element22 to aid insertion into a urethra during a catheterization procedure. To aid insertion into the urethra, it may be desirable for theproximal insertion end38aof theintroducer element22 to be beveled so as to be at an angle of between about 15° and about 30° to an axis of the introducer element.

With regard to theslit24 extending along thelongitudinal axis40 for the entire length of theelongated introducer element22, it may have a width of between about 1.0 mm and 1.5 mm. As for theapplicator28, it may include acollar42 surrounding thefirst end30aof thesheath30 and the applicator defines a stop during insertion of theintroducer element22 into a urethra.

The holdingelement36 may comprise a cord having afirst end36awhich is attached to thesecond end30bof thethin sheath30, and thecord36 may also have asecond end36bwith afinger grip tab44 attached thereto.

Theintroducer element22 may be formed of a flexible material and is preferable formed of a flexible, shape-memory material, such as a flexible shape-memory polymer.Introducer element22 and the other introducer elements disclosed herein may be formed, for example, from polyamides, polyvinylchloride, polypropylene, polyester, polyurethane, polyesterurethane, polyetherurethane, poly(ester-etherurethane), fluoropolymers such as, but not limited to, polyvinylidene difluoride, polyvinylidene fluoride, expanded polytetrafluoroethylene, fluorinated ethylene propylene, perfluroalkoxy and combinations of any of the above listed materials. In one embodiment, the introducer element is constructed from a material that allows the introducer element to be bent into a stowed or compact configuration so that it may be, for instance, coiled and carried in a pocket, if desired, and then changed into a generally straight or slightly curved configuration for use during catheterization.

Introducer element22 also may be reusable and need not be sterile since the portion inserted into the urethra is entirely covered by thesheath30 during a catheterization procedure. Theapplicator26,thin sheath30, and holdingelement36 may be made of biodegradable materials and, preferably, flushable biodegradable materials.Applicator26,thin sheath30, and holdingelement36 may be provided in apackage46, which also may be made of biodegradable materials, in a sterile condition for immediate use when removed (seeFIGS. 7, 7A and 8). The other applicators, thin sheaths and packaging described herein also may be made of such biodegradable materials. Additionally,introducer element22 and the other introducer elements described herein also may be made from such biodegradable materials, preferably flexible biodegradable materials and, more preferably, flexible shape-memory, biodegradable materials.

With regard to the foregoing, the biodegradable materials for forming theapplicator26, thethin sheath30, the holdingelement36,introducer element22 andpackage46 may comprise any of a wide range of materials that are flushable for ease of disposal after use. Potential biodegradable polymers include, but are not limited to: polyalkenedicarboylates, poly(alkylcyanoacrylate), polyamides, polyamide-enamines, polyanhydrides, poly(ϵ-caprolactone), polyesters, polyesterurethane, polyetherurethane, poly(ester-etherurethane), polyglycolide, polyhydroxyalkanoates, polyhydroxybutyrate, poly(hydroxybutyrate-co-valerate), polylactide, poly(p-dioxanone), poly(trimethylene carbonate), polyureas, polyurethane, cellulose, chitin, chitosan, collagen, corn, lignin, soy protein, starch, succinic acid and sugar cane. The flushable material could also be a segmented polymer; a non-degradable polymer mixed with any of the above listed biodegradable polymers, so that at least thesheath30 would eventually decompose into small pieces.

By providing theapplicator26, thethin sheath30, and the holdingelement36 in apackage46, it is possible to provide a flushable intermittent catheter assembly kit48 (seeFIG. 6) having a reusableelongated introducer element22, and a plurality offlushable catheter elements50 each comprising one of thepackages46. As discussed above, each of thepackages46 includes a single, sterile ready-to-use catheter element50 which is comprised of anapplicator26,thin sheath30, and holdingelement36. As shown inFIG. 6, thekit48 may comprise asemi-rigid carrying case52 formed of a paperboard material to have an openable top52a, aholder52bfor theelongated introducer element22, and apocket52cfor, by way of example, a dozen ready-to-use catheter elements50 with four of each disposed in three adjacent rows within thepocket52c.

In an alternative embodiment illustrated inFIGS. 9-12, thesecond end30b′ of thethin sheath30′ may be secured to generally diametricallyopposed portions46aand46bof theapplicator26′ to define the holding element which may be associated with thesecond end30b′ of thesheath30′. With this embodiment which is discussed in detail below, theintroducer element22′ includes a pair of opposed members orarms24a′ and24b′ each extending parallel to thelongitudinal axis40′ of theintroducer element22′ from aproximal insertion end38a′ toward adistal end38b′ thereof.Arms24a′ and24b′ define a slit orgap23′, and preferably a planar slit or gap, therebetween.

As with the earlier embodiment, theapplicator26′ has anopening28′, and thefirst end30a′ of thethin sheath30′ may be secured to theapplicator26′ about theopening28′. Thesecond end30b′ of thethin sheath30′ defines adischarge opening32′ which may be inverted relative to thefirst end30a′ of thesheath30′ and extends into theopening28′ in theapplicator26′ to define inner34a′ and outer34b′ sleeve portions. Theinner sleeve portion34a′ defines aflow path33′ (shown inFIG. 10A) for urine through the discharge opening32′. The catheter assembly20 ‘also may include a holding element36’ (seeFIG. 14) associated with thesecond end30b′ of thesheath30′ for theinner sleeve portion34a′ to be extended through theslit23′ defined byarms24a′ and24b′ such thatinner sleeve portion34a′ is disposed within theintroducer element22′. This serves to separateinner surfaces22a′ ofarms24a′/24b′ of theintroducer element22′ from the urine flow path so theintroducer element22′ is never exposed to urine during a catheterization procedure. Theapplicator26′ receives theintroducer element22′ through theopening28′ and extends theouter sleeve portion34b′ over anouter surface22b′ of theelongated introducer element22′ to separate it from the urethra. Referring toFIG. 10A,sleeve30′ everts over the proximal insertion end38′ ofintroducer element22′ so that theouter sleeve portion34b′ extends overouter surface22b′ andinner sleeve portion34a′ extends overinner surface22a′ ofintroducer element22′. Accordingly, the portion of theintroducer element22′ which is located within the urethra during a catheterization procedure is entirely covered by the inner34a′ and outer34b′ sleeve portions of thesheath30′ and is therefore suitable for reuse.

Theintroducer element22′ comprises a pair of opposed elements orarms24a′ and24b′ which extend longitudinally and define aslit23′ that extends along at least a portion of theintroducer element22′ and preferably from theproximal insertion end38a′ toward thedistal end38b′ ofintroducer element22′. The portion of thearms24a′ and24b′ near theproximal insertion end38a′ of theintroducer element22′ may be rounded, as will be appreciated by referring toFIG. 11, which will facilitate insertion into a urethra during a catheterization procedure. Theelongated introducer element22′ may include a pair ofgripping elements54aand54bassociated with thedistal end38b′ remote from theproximal insertion end38a′ beyondslit23′ (seeFIGS. 9-11).

In addition to the foregoing, theintroducer element22′ in the embodiment illustrated inFIGS. 9-11 may be formed of a flexible, shape-retaining material such as any of the materials described above with respect tointroducer element22 so it can be coiled and carried in a pocket, if desired. As before, theintroducer element22′ is reusable and need not be sterile since the portion inserted into the urethra is entirely covered by thesheath30′ during a catheterization procedure. Also, as before, theapplicator26′, thethin sheath30′, and the holdingelement36′ may be made of flushable biodegradable materials and provided in apackage46′ in a sterile condition for immediate use when removed (seeFIGS. 13 and 14).

By providing theapplicator26′, thethin sheath30′, and the holdingelement36′ in apackage46′, it is possible to provide a flushable intermittentcatheter assembly kit48′ (seeFIG. 15) having a reusableelongated introducer element22′, and a plurality offlushable catheter elements50′ each comprising one of thepackages46′. Each of thepackages46′ includes a single, sterile ready-to-use catheter element50′ which is comprised of anapplicator26′,thin sheath30′, and holdingelement36′. As shown inFIG. 15, thekit48′ may comprise asemi-rigid carrying case52′ formed of paperboard material with an openable top52a′, a holder (not shown) for the introducer element (not shown), and apocket52c′ for, e.g., fifteenpackages46′ of ready-to-use catheter elements (not shown), i.e., three each in five adjacent rows in thepocket52c′.

In use of the embodiment illustrated inFIGS. 1-5, it will be appreciated that one of thecatheter elements50 is first removed from one of thepackages46 after it has been opened (FIG. 7A), following which thegrip tab44 is used to extend theinner sleeve portion34aof thesheath30 while gripping thecollar42. When this has been done, theslit24 is used to locate theinner sleeve portion34awithin the introducer element22 (seeFIGS. 1 and 2). After theinner sleeve portion34aof thesheath30 has been located within the introducer element22 (seeFIG. 2), thecollar42 is used to extend theouter sleeve portion34bover a substantial portion of theouter surface22bof theintroducer element22 to be inserted into the urethra (seeFIGS. 3 and 4).

Following a catheterization procedure, thecollar42 and thegrip tab44 can again be used to remove thesheath30 from the introducer element22 (seeFIG. 5), and thecatheter element50 comprised of theapplicator26, thesheath30 and thegrip tab44 can be flushed down the toilet and the introducer element put away for use at a later time with a freshnew catheter element50.

In use of the embodiment illustrated inFIGS. 9-11, 13 and 14, it will be appreciated that one of thecatheter elements50′ is first accessed by peeling open one of thepackages46′ as shown inFIG. 13. When this has been done, thearms24a′ and24b′ ofintroducer element22′ are inserted through theopening28′ in theapplicator26′ with the two arm portions of the disposed on opposite sides of theinner sleeve portion34a′ which is attached at generally diametricallyopposed portions46aand46bof theapplicator26′ so theinner sleeve portion34a′ is within the introduceelement22′. Next, theintroducer element22′ is fully inserted through theopening28′ in theapplicator26′ causing theinner sleeve portion34a′ and theouter sleeve portion34b′ to be fully deployed (seeFIG. 10).

Referring toFIG. 12, it will be noted that there areopenings56aand56binto which the twoarm portions24a′ and24b′ of theintroducer element22′ can be inserted. As shown, the twoarms24a′ and24b′ are disposed on opposite sides of theinner sleeve portion34a′ and, as noted above, theinner sleeve portion34a′ is attached at generally diametricallyopposed portions46aand46bof theapplicator26′. When theintroducer element22′ is further inserted, it causes theinner sleeve portion34a′ and theouter sleeve portion34b′ of thesheath30′ to “unfold” or “unroll” to cover the inner andouter surfaces22a′ and22b′.

In the position shown inFIG. 10, thegripping elements54aand54bcan be used to insert thecatheter assembly20′ into the urethra for a catheterization procedure. After a catheterization procedure, theintroducer element22′ can be removed from thecatheter element50′, and thecatheter element50′ comprised of theapplicator26′, thesheath30′, and the holdingelement36′, can be removed from thepackage46′ which is preferably formed of plastic in the form of, e.g., a contact lens case. Thecatheter element50′ can then be flushed down the toilet, theplastic package46′ discarded, and theintroducer element22′ put away for later use.

FIGS. 16-26 illustrate another embodiment of an intermittedcatheter assembly120 comprising anelongated introducer element122, anapplicator126 and apackage146. Similar toelongated introducer element22′,introducer element122 includes a pair of opposed members orarms124aand124beach extending parallel to the longitudinal axis of theintroducer element122 from aproximal insertion end138atoward adistal end138bthereof.Arms124aand124bdefine a slit orgap123, and preferably a planar slit or gap, therebetween. At or near thedistal end138bofintroducer element122 is ahandle portion125 which includes a finger or hand grippingmember127 for gripping by a user.Handle portion125 includes adrainage lumen129 therethrough which leads to a drainage opening131 (as best shown inFIG. 26) for the drainage of urine. In addition to the foregoing, theintroducer element122 may be formed of a flexible, shape-retaining material such as any of the materials described above with respect tointroducer element22 so it can be coiled and carried in a pocket, if desired.

As with the earlier embodiments, a sleeve orsheath130 for covering or shrouding theintroducer element122 is attached toapplicator126. Referring toFIGS. 17 and 18,applicator126 also hasopenings128aand128bfor receivingarms124aand124bofintroducer element122. Thefirst end130aof thesleeve130 is secured to theapplicator126 about theopenings128aand128b. As in the previous embodiments,sleeve130 is inverted at121 (FIG. 26) such thatsecond end130bis adjacent or nearfirst end130a. Thesecond end130bofsleeve130 is secured about adrainage lumen137 ofapplicator126, which lumen137 leads to drainage opening139 (FIG. 18). In the illustrated embodiment,drainage lumen137 is defined by aproximally extending stem135 to whichsecond end138bofsleeve130 is connected. Theinverted sleeve130 defines inner134aand outer134bsleeve portions. Theinner sleeve portion134adefines aflow path133 for passage of urine therethrough. Urine passes throughflow path133 defined byinner sleeve portion134aand throughdrainage lumen137 anddrainage opening139 ofapplicator126.

Turning toFIGS. 19-22,applicator126 andsleeve130, optionally, may be packaged in apackage146.Package146 includes a first orintroducer opening148 at or near the top of thepackage146 wherein theopening148 receives and retainsapplicator126 whenapplicator126 andpackage146 are discrete individual pieces. In some embodiments,applicator126 andpackage146 may be formed as a single unitary structure.Package146 defines acavity150 that containssleeve130 in a stowed or folded configuration. There is a second ordeployment opening152 at or near the bottom ofpackage146 for deployment ofsleeve130 whenintroducer element120 is inserted therein. The package may also include acover154 that covers first andsecond opening148 and152. Cover154 is preferably a peelable foil that is sealed about first andsecond opening148 and152. In the illustratedembodiment cover154 includes a first portion156 that coversopening148 and a second portion158 that coversopening152. Cover154 also includes a section160 between portions156 and158 so that both portions may be removed from the package with a single movement. In the illustrated embodiment,cover154 is of a one piece construction that extends aroundpackage146 to cover bothopenings148 and152. Other embodiments may include two separate covers wherein each cover covers and seals one of the openings.

In use,cover154 is removed frompackage146 to exposeopenings148 and152. Referring toFIGS. 23-26,introducer element122 is inserted intoapplicator126 andsleeve130 to deploysleeve130 out of opening152 in the bottom ofpackage146. In particular and referring toFIGS. 24-26,arms124aand124bofintroducer element122 are inserted into and throughopenings128aand128bofapplicator126 and into a space162 (FIGS. 24 and 25) betweeninner sleeve portion134aandouter sleeve portion134b.Introducer element122 is advanced throughopenings128aand128buntil theproximal insertion portion138aofintroducer element122 is at the inverted portion131 (FIG. 26) ofsleeve130 anddrainage opening139 ofapplicator126 is aligned and in abutting communication with drainage lumen129 (FIG. 16) ofhandle portion125 ofintroducer element122.Inner sleeve portion134aseparatesinner surfaces122aofarms124a/124bof theintroducer element122 from the urine flow path so thatinner surfaces122aofintroducer element122 are never exposed to urine during a catheterization procedure. Additionally,outer sleeve portion134bcoversouter surfaces122bofarms124a/124bof theelongated introducer element122 to separate them from the urethra. Accordingly, the portion of theintroducer element122 which is located within the urethra during a catheterization procedure is entirely covered by the inner134aand outer134bsleeve portions of the sheath orsleeve130 and is therefore suitable for reuse.

The user may use a gripping portion164 (FIG. 23) ofpackage146, such as the illustrated finger tab, and handle125 of theintroducer element122 to assist in positioning and insertingcatheter assembly120 into the urethra.Catheter assembly120 is inserted through the urethra untilproximal end portion138aenters the bladder. Urine drains throughflow path133 defined byinner sleeve portion134a,lumen137 applicator126 (FIG. 17),drainage lumen127 and out ofdrainage opening131 ofhandle125 into a suitable collection receptacle. After drainage of the bladder is completed,catheter assembly120 is retracted from the urethra.Introducer element122 is removed fromsleeve130 andapplicator126.Sleeve130,applicator126 andpackage146 are then disposed of. In one embodiment,sleeve130,applicator126 andpackage146 are made of flushable materials that may be disposed of by flushing down the toilet. Such materials may be water soluble or degradable materials. In other embodiments,sleeve130 andapplicator126 may be made of flushable materials and are separable frompackage146. In such embodiments,sleeve130 andapplicator126 may be disposed of in the toilet andpackage146 is disposed of in an appropriate waste collection container. As before, theintroducer element122 is reusable and need not be sterile since the portion inserted into the urethra is entirely covered by thesheath130 during a catheterization procedure.

FIGS. 27-36 illustrate yet anothercatheter assembly220 of the present disclosure.Catheter assembly220 includes an elongated introducer element222 (shown inFIGS. 30, 31 and 36), anapplicator226,sleeve230 and, optionally, a package of246. Similar toelongated introducer element22,elongated introducer element222 may be formed of a flexible material and is adapted for insertion into a urethra during a catheterization procedure. As shown inFIGS. 30 and 31,introducer element222 has at least oneslit224 extending longitudinally along a portion of its length and preferably at least a substantial portion of its length.

Turning toFIGS. 29-33,applicator226 includes a first orouter passageway228 extending throughapplicator226 and having proximal opening228aand adistal opening228b. A thin sheath, sleeve orshroud230 has afirst end230asecured to theapplicator226 aboutproximal opening228aofpassageway228. As in the previous embodiments,sleeve230 is inverted about221 (FIG. 29) such that asecond end230bofsleeve230 is adjacent or nearfirst end230a. Thesecond end230bofsleeve230 is secured about adrainage passageway237 ofapplicator226. In the illustrated embodiment,passageways228 and237 are defined by a proximally extending stem235 projecting from aproximal surface223 ofapplicator226.Passageway237 leads to and is in fluid communication withdrainage tube227 distally extending from adistal surface225 ofapplicator226.Drainage tube227 includes adrainage opening239.

Inverted sleeve230 defines inner234aand outer234bsleeve portions.Inner sleeve portion234adefines aflow path233 for passage of urine therethrough. Urine passes throughflow path233 and throughpassageway237,drainage tube227 anddrainage opening239 ofapplicator226.

Turning toFIGS. 30-31, to insertintroducer element222 intoapplicator226,drainage tube227 is aligned and inserted intoproximal insertion end238aofintroducer element222.Drainage tube227 functions as guide member to align and guideproximal insertion end238aofintroducer element222 to opening228b. In the illustrated embodiment, opening228bhas the generally the same profile asintroducer element222. As illustrated inFIGS. 32 and 33,introducer element222 is inserted throughpassageway228 and into thespace241 defined betweeninner sleeve portion234aandouter sleeve portion234b.Introducer element222 is inserted intopassageway228 until proximal insertion end reachesinverted portion221 ofsleeve230, as illustrated inFIG. 36.Inner sleeve portion234aserves to separate and shroud an inner surface222a(FIGS. 30-33) of theintroducer element222 from the urine flow path so thatintroducer element222 is never exposed to urine during a catheterization procedure. Additionally,outer sleeve portion234bextends over and shrouds anouter surface222b(FIGS. 30-33) of theelongated introducer element222 to separate it from the urethra. Accordingly, the portion of theintroducer element222 which is located within the urethra during a catheterization procedure is entirely covered by the inner234aand outer234bsleeve portions of thesheath230 and is therefore suitable for reuse.

Referring toFIGS. 27, 28, 34 and 35,applicator226 andsleeve230, optionally, may be packaged in apackage246.Package246 includes afirst cavity250 for containingapplicator226 and a secondedcavity252 for containingsleeve230 in a folded or rolled up condition. Thepackage246 may include a cover or seal254 covering the top of thepackage246. Preferably, thecover254 is a peelable seal.

Referring toFIGS. 34 and 35, in use,cover254 is removed frompackage246 anddrainage tube227 is lifted or tilted at an angle by the user.Drainage tube227 is aligned and inserted into theproximal insertion end238aofintroducer element222. Theintroducer element222 is advanced and guided bydrainage tube227 intodistal opening228bofpassageway228 ofapplicator226, as described above.Introducer element222 is advanced throughpassageway228 by the user gripping and pullingapplicator226 alongintroducer element222 or by continued insertion of introducer element intopassageway228 withapplicator226 is held stationary.Introducer element222 is advanced throughpassageway228 and through thespace241 between inner andouter sleeve portions234a/234buntil theproximal insertion portion238aofintroducer element222 reachesinverted portion221 ofsleeve230 anddrainage tube227 ofapplicator226 extends out of distal end portion238bofintroducer element222, as illustrated inFIG. 36.

The user may gripapplicator226 to assist inpositioning catheter assembly220 and inserting it into the urethra.Catheter assembly220 is inserted through the urethra untilproximal end portion238aenters the bladder. Urine drains through flow path231 defined byinner sleeve portion234aand throughpassageway237 anddrainage tube227 ofapplicator226.Drainage tube226 extends beyond the distal end portion238bofintroducer element222 to reduce the chances of urine coming into contact with the distal end portion238bofintroducer element222. After drainage of the bladder is completed, catheter assembly is retracted from the urethra.Introducer element222 is removed fromsleeve230 andapplicator226.Sleeve230 andapplicator226 are then disposed of. As before, theintroducer element222 is reusable and need not be sterile since the portion inserted into the urethra is entirely covered by thesheath230 during a catheterization procedure. Also, as before, theapplicator226 andsleeve230 may be made of flushable biodegradable materials.

FIGS. 37-39 disclose one embodiment of anintroducer element322 of the present disclosure, which may be used with the applicators disclosed herein. Similar toelongated introducer element22,elongated introducer element322 may be formed of a flexible material and is adapted for insertion into a urethra during a catheterization procedure.Introducer element322 has at least oneslit324 extending longitudinally along a portion of its length and preferably at least a substantial portion of its length.

Introducer element322 also may include different flexibility and stiffness characteristics along its lengths to impart varying flexibility to theintroducer element322.FIGS. 37 and 38show introducer element322 divided into four sections, wherein the sections have different flexibilities relative to adjacent sections.Introducer322 includes a firstproximal section326, asecond section328, athird section330 and afourth section332. The firstproximal section326 is configured to be inserted through the urethra and into the bladder.First section326 may be relatively more flexible thansecond section328.Second section328 is positioned adjacent to and distally offirst section326 and is relatively more rigid thanfirst section326. Athird section330 is positioned adjacent and distally ofsecond section328.Third section330 is relatively more flexible thansecond section328 andfourth section332, which is positioned distally ofthird section330 and relatively more rigid than the third section. As illustrate inFIG. 38, the first andthird sections326 and330 are flexible while the second and fourth328 and332 are substantially rigid and remain generally linear.

The flexibility/rigidity of each section may be varied by varying the type or thickness of the material or by creating flexure areas, such as slits or cut-outs. In some applications, varying the flexibility/rigidity of the introducer along its length assists in inserting and traversing the introducer element and sleeve through the tortuous pathway of the male urethra.

FIG. 39 illustrates some exemplary configurations of the proximal insertion end, generally designated338, of the introducer element, generally designated322. For example,element322aincludes an angledproximal insertion end338a.Introducer elements322band322cinclude more blunted proximal end insertion ends338band338c, respectively.

FIGS. 40-43 illustrate another embodiment of acatheter assembly420 of the present disclosure. As illustrated inFIGS. 40 and 41,catheter assembly420 includes anintroducer element422 and a sheath, sleeve orshroud430.Sleeve430 is similar to the other sleeves described above and is formed of a thin material.Sleeve430 is inverted at421 to form aninner portion434aand anouter portion434b.Inner portion434adefines aflow path431 having adrainage opening432 for the passage of urine therethrough. As will be explained in more detail below, aspace435 for receiving theintroducer element422 is defined between inner434aand outer434bportions ofsleeve430.

As shown inFIGS. 41-43,introducer element422 includes a proximalinsertion end portion438aand adistal end portion438b.Introducer element422 also includes aslit424 at least partially along, and preferably substantially along, the entire length ofintroducer element422. Ahandle425 may be located at thedistal end portion438bfor gripping by the user.

In use, the user insertsproximal insertion end438ainto thespace435 defined betweeninner portion434aandouter portion434bofsleeve430. Theinner portion434amay include grippingportion440 designated for gripping the inner portion. Similarly, theouter portion434balso may have agripping portion442 for gripping the outer portion. The grippingportions440 and442 may be designated by color or texture. It is preferable for the user to use the gripping portions so that the user recognizes and utilizes the gripping portions of the sleeve to handle the sleeve. Handling the sleeve by the designated gripping portions reduces the risk of contamination of the portion of the sleeve inserted into the urethra because the portions inserted into the urethra are not contacted by the user's fingers.

After theproximal insertion end438ahas been inserted intospace435,inner portion434aofsleeve430 is gripped by the user at grippingportion440 and pulled along the length ofintroducer element422.Inner portion434ais then or simultaneously inserted intoslit424 ofintroducer element422. Referring toFIG. 42,outer portion434bofsleeve430 is then gripped by grippingportion442 and pulled along the length ofintroducer element422 untilouter portion434bcovers the surface ofintroducer element422.

The user may grip handleportion425 ofintroducer element422 to insert andadvance catheter420 into and through the urethra.Catheter assembly420 is inserted through the urethra untilproximal end portion438aenters the bladder. Urine drains through aflow path431 defined byinner sleeve portion434aand out ofdrainage opening432 into a suitable collection receptacle.Drainage opening432 is located beyond thedistal end portion438bofintroducer element422 to reduce the chances of urine coming into contact with thedistal end portion438bofintroducer element422. After drainage of the bladder is completed, catheter assembly is retracted from the urethra.Introducer element422 is removed fromsleeve430 andsleeve430 is then disposed of. As before, theintroducer element222 is reusable and need not be sterile since the portion inserted into the urethra is entirely covered by thesheath230 during a catheterization procedure. Also as before,sleeve430 may be made of flushable biodegradable materials and disposed of in a toilet.

While in the foregoing there have been set forth different embodiments of the disclosure, it will be appreciated that they have been provided for purposes of illustration only and the disclosure is not limited to these embodiments but is only limited to what falls within the scope of the appended claims.

Claims (30)

What is claimed is:

1. An intermittent catheter assembly, comprising:

an elongated introducer element having a proximal insertion end and a distal end remote from the proximal insertion end, the elongated introducer element being formed of a flexible material adapted for insertion into a urethra during a catheterization procedure, the elongated introducer element having at least one slit extending longitudinally along at least a portion of the elongated introducer element;

a sheath having a first end and a second end being inverted relative to the first end of the sheath to define inner and outer sleeve portions and a space therebetween, the inner sleeve portion defining a flow path for urine;

the elongated introducer element being disposed in the space defined between the inner and outer sleeve portions, the inner sleeve portion being extendable through the at least one slit of the elongated introducer element so as to be disposed within the elongated introducer element and cover an inner surface of the elongated introducer element to thereby separate the inner surface of the elongated introducer element from the urine flow path, and the outer sleeve portion extending over an outer surface of the elongated introducer element to thereby separate the outer surface of the elongated introducer element from the urethra.

2. The intermittent catheter assembly ofclaim 1 further including a holding element associated with the second end of the sheath for extending the inner sleeve portion through the at least one slit of the elongated introducer element.

3. The intermittent catheter assembly ofclaim 2 wherein the holding element comprises a cord having a first end attached to the second end of the sheath, the cord also having a second end with a finger grip tab attached thereto.

4. The intermittent catheter assembly ofclaim 2 wherein the sheath and the holding element are formed of a flushable material.

5. The intermittent catheter assembly ofclaim 2 wherein the sheath and the holding element are formed of a biodegradable material.

6. The intermittent catheter assembly ofclaim 1 further including an applicator having at least one opening for receiving the elongated introducer element therethrough, and the first end of the sheath being secured to the applicator about the at least one opening.

7. The intermittent catheter assembly ofclaim 6 wherein the applicator comprises a collar generally surrounding the first end of the sheath and defines a stop during insertion of the elongated introducer element into a urethra.

8. The intermittent catheter assembly ofclaim 6 wherein the second end of the sheath is secured to generally diametrically opposed portions of the applicator.

9. The intermittent catheter assembly ofclaim 6 wherein the applicator includes a drainage lumen wherein the second end of the sheath is secured about the drainage lumen so that the urine flow path defined by the inner sleeve portion is in fluid communication with the drainage lumen.

10. The intermittent catheter assembly ofclaim 9 wherein the drainage lumen is at least partially defined by a drainage tube that extends distally from a distal surface of the applicator.

11. The intermittent catheter ofclaim 10 wherein the drainage tube functions as a guide for guiding insertion of the elongated introducer element into the at least one opening of the applicator.

12. The intermittent catheter assembly ofclaim 6 wherein the applicator includes two openings for receiving the elongated introducer element and the elongated introducer element includes a pair of opposed arms wherein each arm is received into one of the openings and into the space defined between the outer and inner sleeve portions.

13. The intermittent catheter assembly ofclaim 1 wherein the elongated introducer element comprises a tube having a single slit extending along the entire length thereof from the proximal insertion end to the distal end.

14. The intermittent catheter assembly ofclaim 1 wherein the proximal insertion end of the elongated introducer element is beveled to be at other than a right angle to an axis of the elongated introducer element to aid insertion into a urethra during a catheterization procedure.

15. The intermittent catheter assembly ofclaim 1 wherein the proximal insertion end of the elongated introducer element is beveled so as to be at an angle of between about 15° and about 30° to an axis of the elongated introducer element.

16. The intermittent catheter assembly ofclaim 1 wherein the elongated introducer element includes opposed elongated arms defining the slit therebetween.

17. The intermittent catheter assembly ofclaim 1 wherein the slit extending longitudinally along at least a substantial portion of the length of the elongated introducer element has a width of between about 1.0 mm and 1.5 mm.

18. The intermittent catheter assembly ofclaim 1 wherein the sheath is formed of a flushable material.

19. The intermittent catheter assembly ofclaim 1 wherein the sheath is formed of a biodegradable material.

20. An intermittent catheter assembly, comprising:

an elongated introducer element having a proximal insertion end and a distal end remote from the proximal insertion end, the elongated introducer element being formed of a flexible material adapted for insertion into a urethra during a catheterization procedure, the elongated introducer element having at least one slit extending longitudinally along at least a portion of the elongated introducer element;

an applicator having an opening for receiving the elongated introducer element, and a sheath having a first end secured to the applicator about the opening and a second end defining a discharge opening;

the second end of the sheath being inverted relative to the first end of the sheath and extending into the opening in the applicator to define inner and outer sleeve portions wherein the inner sleeve portion defines a flow path for urine through the discharge opening;

a holding element associated with the second end of the sheath for extending the inner sleeve portion through the at least one slit of the elongated introducer element so as to dispose the inner sleeve portion within the elongated introducer element wherein the inner sleeve portion covers an inner surface of the elongated introducer element to thereby separate the inner surface of the elongated introducer element from the urine flow path; and

as the elongated introducer element is inserted through the opening of the applicator, the outer sleeve portion extends over an outer surface of the elongated introducer element.

21. The intermittent catheter assembly ofclaim 20 wherein the proximal insertion end of the elongated introducer element is beveled to be at other than a right angle to an axis of the elongated introducer element to aid insertion into a urethra during a catheterization procedure.

22. The intermittent catheter assembly ofclaim 20 wherein the proximal insertion end of the elongated introducer element is beveled so as to be at an angle of between about 15° and about 30° to an axis of the elongated introducer element.

23. The intermittent catheter assembly ofclaim 20 wherein the elongated introducer element comprises a tube having a single slit extending along the entire length thereof from the proximal insertion end to the distal end.

24. The intermittent catheter assembly ofclaim 20 wherein the elongated introducer element comprises a pair of opposed elongated arms that define the slit therebetween.

25. The intermittent catheter assembly ofclaim 20 wherein the slit extending longitudinally along at least a substantial portion of the length of the elongated introducer element has a width of between about 1.0 mm and 1.5 mm.

26. The intermittent catheter assembly ofclaim 20 wherein the applicator comprises a collar generally surrounding the first end of the thin sheath and also defining a stop during insertion of the elongated introducer element into a urethra.

27. The intermittent catheter assembly ofclaim 20 wherein the holding element comprises a cord having a first end attached to the second end of the thin sheath, the cord also having a second end with a finger grip tab attached thereto.

28. The intermittent catheter assembly ofclaim 20 wherein the second end of the thin sheath is secured to generally diametrically opposed portions of the applicator to define the holding element associated with the second end of the sheath.

29. The intermittent catheter assembly ofclaim 20 wherein the applicator, the sheath and the holding element are formed of a flushable material.

30. The intermittent catheter assembly ofclaim 20 wherein the applicator, the sheath and the holding element are formed of a biodegradable material.

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